Artificial Pancreas Device Systems Market By Type (Threshold Suspend Device Systems, Hybrid Closed-Loop Systems, Control-to-Range (CTR) Systems, Control-to-Target (CTT) Systems, Fully Closed-Loop Systems), By Component (Continuous Glucose Monitor {Sensors, Transmitters, Receivers}, Insulin Pump {Tubed Pumps, Tubeless Pumps}, Others); By Technology (Single-Hormone Systems, Dual-Hormone Systems, Others), By Insulin Delivery Method (Subcutaneous Insulin Delivery, Intraperitoneal Insulin Delivery), By Distribution Channel (Online Retail, Hospitals, and Specialty Pharmacies, Retail Pharmacies), By End-User (Hospitals and Clinics, Home Care Settings, Specialized Diabetes Clinics, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Artificial Pancreas Device Systems Market accounted for USD 342.5 Million in 2024 and is expected to reach USD 2,278.5 Million by 2035, growing at a CAGR of around 18.8% between 2025 and 2035. The Artificial Pancreas Device Systems Market concerns sophisticated healthcare products that help diabetics, especially Type 1, to regulate their blood sugar through technological assistance. Some of these systems combine the use of CGMs and insulin pumps and use algorithms to administer correct insulin quantities.

APDS provides designs depending on the level of threshold, suspend, and control offered by implantable solutions, starting with threshold suspend device systems, partial closed-loop systems, and fully closed-loop systems. Market growth is attributed to factors such as rising diabetes incidence, technology expansion, and the trend of migrating from semi-automated to hybrid and fully automated systems. They are CGM sensors, tubed/tubeless insulin pumps, and dual-hormone systems. Target customers are clinics, home health care, and certain specialized diabetes care centers; distributors are internet retailers and hospitals; the actual user of the product is the retail pharmacy.

Report Scope:

Market Dynamics

Technological advancements in glucose monitoring and insulin delivery systems.

Technological advancements in glucose monitoring and insulin delivery systems are key drivers for the growth of the Artificial Pancreas Device Systems Market. Closed-loop insulin administration systems and CGM data transmission are two examples of technologies that have enhanced diabetes care, improved patient outcomes, and reduced the burden of diabetes management. These devices regulate insulin and improve glycemic control by utilizing wireless technologies and improved mathematical algorithms. In 2021, 38.4 million people of all ages had diabetes, accounting for 11.6% of the population, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Of those individuals, 38.1 million were adults aged 18 and older. The Market solutions are anticipated to grow as more people use and become aware of these technologies.

Integration of AI and machine learning optimizes device efficiency and personalization.

The use of artificial intelligence and machine learning in artificial pancreas device systems (APDS) has advanced recently, improving both the implementation of individual parameters and the efficiency of the current devices that drive the market. To provide insulin-dosing strategies according to each patient's needs, a number of machine-learning algorithms determine who should forecast real-time glucose readings.

This improves the glycemic level of control and reduces the avoidable negative effects of hypoglycemia. Most significantly, ML improves the utilization of these systems by determining their usage trends and maximizing their long-term advantages. According to an NIH report, millions of people's chronic illness treatment could be improved by integrating AI into healthcare, highlighting the role that APDS technologies play in improving and developing the market.

The high costs of artificial pancreas devices limit accessibility for patients.

The high cost of artificial pancreas device systems (APDS) is a significant barrier to accessibility and affordability, which limits the Artificial Pancreas Device Systems Market growth. These devices, which include sensors, insulin pumps, and advanced algorithms, have required significant financial outlays for both manufacturing and research and development.

Costs are further raised by the added requirements for upkeep, new sensors, and software updates. These expenses are frequently too high for people without insurance or with insufficient insurance, which hinders the widespread use of such devices. The necessity for industry stakeholders to make pertinent efforts toward cost optimization by integrating efficient production lines, subsidies, and other measures to promote access is highlighted by this cost component.

Growing investment in R&D fosters innovation in dual-hormone delivery systems.

Increased research spending in the Artificial Pancreas Device Systems Market offers a great opportunity for innovative ideas to surface in the form of dual-hormone delivery systems. They work similarly to insulin and glucagon; however, they are not as good at controlling the glycemic level as other systems. To clear the path for future solutions, more grants are being allocated to the development of novel biosensors, micro-pumps, and real-time algorithms.

 In addition to making artificial pancreas device systems more appealing and palatable to a larger audience, it also amplifies their advantages. As R&D activities expand within the APDS industry, dual-hormone systems are expected to become a very active segment.

The development of compact, user-friendly devices enhances patient compliance and usage.

The availability and portability of small hardware products are some of the major opportunities in the Artificial Pancreas Device Systems Market. Even as technology grows, manufacturers are widely concerned with developing devices that can be easily employed by patients in their daily routines. These small-sized devices are worn on the person, thus encouraging the usage of the recommended treatment plans.

Improved interfaces and functions allow those with diabetes to effectively monitor and regulate the disease without being overwhelmed by complicated products. Furthermore, while small and portable devices provide comfort and discretion to the patients, they may enhance patients’ compliance and, in turn, therapeutic efficacy. These shifts in artificial pancreas systems towards a user-centric interface cause it to become more inviting and consequently increase adoption for those who want more convenient ways in which to regulate their diabetes.

Industry Experts Opinion

"The development of artificial pancreas systems offers a transformative approach for managing type 1 diabetes. These systems simulate the function of a healthy pancreas by dynamically adjusting insulin delivery, improving quality of life for patients, and offering better control over glucose levels."

• Dr. Roman Hovorka, Professor of Metabolic Medicine at the University of Cambridge

Segment Analysis

Based on the type, the Artificial Pancreas Device Systems Market is classified into threshold suspend device systems, hybrid closed-loop systems, control-to-range (CTR) systems, control-to-target (CTT) systems, and fully closed-loop systems. In the Artificial Pancreas Device Systems Market, hybrid closed-loop systems are the largest category. These systems are the most common because they integrate CGM with insulin delivery systems, allowing them to automatically change insulin dosages while allowing the user to enter other relevant data, such as meal information.

They achieve the right ‘tight plus safe’ balance and communicate significant enhancement in glycemic control versus hypoglycemic risk. This is fueled by the advancement of algorithms, the growing acceptance of the solutions in regulated markets, and the desire of diabetic patients and medical professionals to attain better diabetes control. Consequently, the primary forces behind the robust market expansion are hybrid closed-loop systems.

Based on the components, the Artificial Pancreas Device Systems Market is classified into continuous glucose monitors, insulin pumps, and others. Continuous Glucose Monitors (CGMs) are the largest product in the Artificial Pancreas Device Systems Market. Since sensors provide frequent data updates on blood glucose levels, enabling prompt insulin administration, they appear to be a crucial subset of CGMs.

The need to provide precise glucose readings as input for automated control makes them crucial in closed-loop artificial pancreas systems. The prevalence of diabetes in particular has increased, and the developed technology improves sensor durability, mobility, and performance measurement. CGMs are a primary market segment and propel the growth of this market since they are essential to the functioning of artificial pancreas device systems.

Regional Analysis

The North American Artificial Pancreas Device Systems Market is growing due to its various R&D centers, and doctors’ active usage of innovative technologies for treating diabetics makes it the region with great potential for the Artificial Pancreas Device Systems Market. The region also has a good relationship with regulatory bodies, and the reimbursement policies encourage the use of advanced diabetes management systems.

Increased knowledge regarding the application of artificial pancreas devices by both patients and healthcare practitioners contributes to market expansion. Furthermore, the high incidence of type 2 diabetes and the growing need for better glycemic management contribute to the use of these systems. Healthcare organizations, IT companies, and governments have a significant role in developing the application and making it easier and more innovative in this market.

The Asia-Pacific Artificial Pancreas Device Systems Market is growing rapidly because of the unlimited growth rate in the region due to the increased incidence of diabetes and increasing health consciousness. The presence of modern healthcare facilities is coupled with increasing research and development budgets conducive to market growth.

Better diabetes management strategies are currently being used in the region as a result of ongoing educational and public awareness campaigns. The market's natural growth is being extended by hospitals and clinics and also by advantageous government regulations and alliances between local and foreign sector participants. There are trained healthcare personnel in the area, and the costs of new and sophisticated medical technologies are decreasing, which could lead to excellent development opportunities in this field.

Competitive Landscape

The Artificial Pancreas Device Systems Market is already a vigorous competitive market owing to the innovation of diabetes management solutions and the rising use of closed-loop insulin delivery systems. Several manufacturers in the market are currently involved in the research and development of new technology, including Medtronic Insulet Corporation, Tandem Diabetes Care, Beta Bionics, and Dexcom, among others. Medtronic’s MiniMed series and Tandem’s t: slim X2 insulin pump, together with Dexcom’s continuous glucose monitoring (CGM) system integration, have become industry standards. The industry is highly investing in the growth of the product lines, approval from regulatory bodies, and increasing the connectivity of the systems through artificial intelligence and IoT. Competition deepens with strategic partnerships and joint ventures, together with mergers and acquisitions, all in a bid to lower the costs of its services. The market will continue to expand due to increased diabetes rates worldwide and because it stimulates product development and market competition among major players.

Artificial Pancreas Device Systems Market, Company Shares Analysis, 2024

To explore in-depth analysis in this report - Request Free Sample Report

Recent Developments:

• In July 2024, Tandem Diabetes Care Inc. introduced an updated t: slim X2 insulin pump software, designed to work seamlessly with the Dexcom G7 and G6 Continuous Glucose Monitoring (CGM) systems, with Health Canada acting as the authorized distributor.
• In June 2024, MCRA, the largest privately held independent Clinical Research Organization (CRO) and consultancy specializing in medical devices, diagnostics, and biologics, announced its role in helping CamDiab secure FDA clearance in the United States for its artificial pancreas software, CamAPS FX.

Report Coverage:

By Type

• Threshold Suspend Device Systems
• Hybrid Closed-Loop Systems
• Control-to-Range (CTR) Systems
• Control-to-Target (CTT) Systems
• Fully Closed-Loop Systems

By Component

• Continuous Glucose Monitor (CGM)
  • Sensors
  • Transmitters
  • Receivers
• Insulin Pump
  • Tubed Pumps
  • Tubeless Pumps
• Others

By Technology

• Single-Hormone Systems
• Dual-Hormone Systems
• Others

By Insulin Delivery Method

• Subcutaneous Insulin Delivery
• Intraperitoneal Insulin Delivery

By Distribution Channel

• Online
• Hospitals and Specialty Pharmacies
• Retail Pharmacies

By End-user

• Hospitals and Clinics
• Home Care Settings
• Specialized Diabetes Clinics
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Medtronic plc
• Bigfoot Biomedical
• Johnson & Johnson
• Tandem Diabetes Care, Inc.
• Beta Bionics, Inc.
• Insulet Corporation
• Dexcom, Inc.
• Defymed
• Admetsys Corporation
• Inreda Diabetic B.V.
• TypeZero Technologies, LLC
• Diabeloop
• Roche Diabetes Care
• Ypsomed
• CamDiab
• Zyoxel

 

Frequently Asked Questions (FAQs)